E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsing multiple sclerosis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028245 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To increase the knowledge on the safety and tolerability profile of the IFNB-1b 500 ᄉg dose |
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E.2.2 | Secondary objectives of the trial |
To increase the knowledge on neutralizing activity to IFNB-1b and on patient-reported outcomes (PRO) |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Completion of the BEYOND study 306440 as scheduled (i.e. no premature EOS in study 306440) 2. Relapsing multiple sclerosis (i.e. including SPMS with superimposed relapses) 3. Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction. 4. Females of child-bearing potential: - Agreement to practice adequate contraception methods (intra-uterine contraceptive device [IUCD], condoms, oral contraceptives, or other adequate barrier contraception) and - Negative pregnancy test (urine test and blood sampling for serum test at first visit) and - No lactation 5. Written informed consent |
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E.4 | Principal exclusion criteria |
1. Serious or acute heart diseases such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure 2. History of severe depression or suicide attempt, or current suicidal ideation 3. Epilepsy not adequately controlled by treatment 4. Known allergy to IFNs, to human albumin or to mannitolClinical Study Protocol 5. The following pre-treatments within the specified time frames prior to study enrolment: 6 months before study entry: - Natalizumab (Tysabri) 3 months before study entry: - Any other monoclonal antibody treatment - Azathioprine - Cyclophosphamide - Cyclosporine A - Cladribine - Mitoxantrone - Any other immuno-modulating or immuno-suppressive drugs including other recombinant or non-recombinant cytokines Exceptions: IFNB-1b, glatarimer acetate, systemic corticosteroids, or ACTH - Any other treatment known to be used for putative or experimental MS treatment (exceptions: statins for treatment of hypercholesterinemia or pentoxifylline). 6. Current or past (within the last 2 years) alcohol or drug abuse 7. Inability to administer subcutaneous injections either by self or by caregiver 8. Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary variable for this BEYOND Follow-up study will be the frequencies of the following medical events known to be potentially associated with s.c. treatment of IFNB 1b: 5. Flu-like-syndrome This variable will consist of a combination of MedDRA terms indicative for this condition. 6. Injection site reactions This variable will consist of a combination of MedDRA terms indicative for this condition. 7. Liver enzyme elevations This variable will include all patients with an elevation of either AST/SGOT, or of ALT/SGPT, or of g GT, using the respective laboratory's upper limits of normal. 8. Hematological abnormalities This variable will include all patients with decreased counts of white blood cells, platelets, neutrophil granulocytes, or lymphocytes, or a decreased hemoglobulin level, according to the respective laboratory's lower limits of normal. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
2 fasi consecutive A e B (A: 1 gruppo in aperto e 2 gruppi in doppio cieco; B: 3 gruppi in aperto |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |